A Valencia COVID-19 testing lab that was found to have “significant deficiencies” during a recent state inspection says it has corrected the problems and believes the facility is not in danger of closure.
The $25 million Valencia Branch Laboratory at 28545 Livingston Ave. was unveiled in late October and began processing tests Nov. 1. The 134,000-square-foot facility was converted for its new use by the Massachusetts-based diagnostics company PerkinElmer, which operates the lab under a $1.7 billion contract with the state.
During a routine Dec. 8 inspection, the Laboratory Field Services division of the California Department of Public Health found that out of more than 1.5 million tests performed, the lab had issued corrected reports for about 60 samples and was unable to test roughly 250 samples because of lab errors.
The lab, which employs 600 workers, received the results of that inspection Friday, Feb. 19 and has until March 1 to formally respond with how it has addressed or will address the problems.
In a statement issued Monday, Feb. 22, PerkinElmer said the deficiencies have “long since been resolved.”
During the months of December and January, the lab supplied additional information at LFS’s request, the company said, adding that it appears the agency has “not yet incorporated this extensive information into its routine inspection report.”
“We uphold the highest quality and safety standards across all of our operations, and we have already addressed the issues that emerged in the early days since the Valencia testing site was established,” PerkinElmer President and CEO Prahlad Sing said.
The lab also had an inspection Friday, Feb. 19 for accreditation with the College of American Pathologists, a third-party independent entity. PerkinElmer said it “fully expects a prompt and positive response.”
The lab doesn’t need CAP certification to remain in operation. But it would provide a vote of confidence, the company said.
Whistleblower allegations
More than half a dozen whistleblowers have alleged that some lab technicians at Valencia Branch Laboratory slept while tests were processed and that test swabs were found in restrooms, according to a report from CBS 13 in Sacramento.
Whistleblowers have pointed to a lack of qualified lab techs, a lack of qualified supervisors and constantly changing test protocols.
PerkinElmer said confusion about its laboratory practices and the accreditation process is “misplaced.”
‘Growing pains’
Health and Human Services Secretary Dr. Mark Ghaly said the deficiencies identified by LFS were taken seriously, although they reflect the fact that the lab was set up on an accelerated time frame.
“We knew that there might be growing pains that would require work and process improvements,” Ghaly said in a statement.
When the lab opened it was expected to handle up to 150,000 tests per day by March with a turnaround time of 24 to 48 hours. But records from early February indicate they were processing an average of fewer than 20,000 tests a day.
PerkinElmer said the lab can accommodate up to 100,000 tests per day.
The facility uses polymerase chain reaction diagnostic testing. Sometimes referred to as “molecular photocopying,” the process is a fast and inexpensive technique used to “amplify,” or copy, small segments of DNA. It has proven useful for the detection of bacteria and viruses.
